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FDA 510(k)

GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT

K-Number: K092667 · 2010-06-03

ApplicantGenx Intl., Inc.
Decision Date2010-06-03
Product CodeMQL
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT is the device name listed in this FDA 510(k) record. The listed applicant is Genx Intl., Inc.. It received FDA 510(k) clearance on 2010-06-03 under 510(k) number K092667. The device is classified under product code MQL. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT?

GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT is a medical device that received FDA 510(k) clearance on 2010-06-03. The listed applicant is Genx Intl., Inc.. The 510(k) number is K092667.

When did GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT receive FDA 510(k) clearance?

GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT received FDA 510(k) clearance on 2010-06-03, under 510(k) number K092667.

Who is the listed applicant for GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT?

The FDA 510(k) record lists Genx Intl., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT?

The FDA product code for GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT is MQL.

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Other records listing Genx Intl., Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K112083LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPESK092963GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3K092578LIFEGLOBAL PROTEIN SUPPLEMENTK083509LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSAK080395SUNIVF DISHESK070689LG SPERM FREEZING

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Related Devices (Code: MQL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254261Vitrification Freeze Kit and Thawing Kit (CS-IVF-FK; CS-IVF-TK)CELL STORE (BEIJING) BIOTECHNOLOGY CO., LTD.K260248Ultra-Fast WarmKitazato CorporationK252672CaseBio™ Culture w/HSA (CMH5); CaseBio™ Handling w/HSA (WHH5)Casebioscience, Inc.K250445Fast Warm - NXFujifilm Irvine ScientificK251637Dewin Reproductive Media (Dewin Gamete Buffer [with HSA and without HSA]; Dewin Follicle Flushing Solution, Dewin One Step medium [with HSA and without HSA])Donnevie Medical Technology (Shanghai) Co. , Ltd.K251305Ultra-Fast Vitri; Ultra-Fast WarmKitazato Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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